Endoprosthesis for the penis and a method of endoprosthetic repair

ABSTRACT

Two bars made of an alloplastic material are interconnected by a cross-piece which, when the prosthesis is installed in the penis, is disposed at the pubic bone and serves as a support for the prosthesis. The opposite ends of the bars have spherical bulges disposed near the glans when the prosthesis is placed in the cavernous bodies. Endoprosthetic repair consists in incising the skin, the subcutaneous connective tissue and the penis fascia at the base of the cavernous bodies. Between the fascia and the albuginea tunica of the cavernous bodies channels are formed, through which the endoprosthesis is inserted, with its spherical bulges directed toward the glans, until these bulges are immersed in the cavernous bodies near the glans. The cross-piece is positioned at the pubic bone. Then the endoprosthesis is sutured to the surrounding tissues, the ligature being passed through the orifices in the endoprosthesis.

United States Patent [191 Kalnberz m1 3,832,996 [4 1 Sept. 3, 1974 ENDOPROSTHESIS FOR THE PENIS AND A METHOD OF ENDOPROSTHETIC REPAIR [76] Inventor: Viktor Konstnatinovich Kalnberz,

ulitsa Stendera l3, kv. 2, Riga, USSR.

[22] Filed: Jan. 15, 1973 [21} Appl. N0.: 323,364

[30] Foreign Application Priority Data OTHER PUBLICATIONS I Pearman Dow Corning Bulletin July 1966, p. 10.

Primary Examiner-Lawrence W. Trapp Attorney, Agent, or Firm-Holman & Stern [5 7 ABSTRACT Two bars made of an alloplastic material are interconnected by a cross-piece which, when the prosthesis is installed in the penis, is disposed at the pubic bone and serves as a support for the prosthesis. The opposite ends of the bars have spherical bulges disposed near the glans when the prosthesis is placed in the cavernous bodies. Endoprosthetic repair consists in incising the skin, the subcutaneous connective tissue and the penis fascia at the base of .the cavernous bodies. Between the fascia and the albuginea tunica of the cavernous bodies channels are formed, through which the endoprosthesis is inserted, with its spherical bulges directed toward the glans, until-these bulges are immersed in the cavernous bodies near the glans. The cross-piece is positioned at the pubic bone. Then the endoprosthesis is sutured to the surrounding tissues, the ligature being passed through the orifices in the endoprosthesis.

7 Claims, 6 Drawing Figures The present invention relates to surgical methods of treatment of impotence, and more particularly, to endoprosthesis for the penis.

For the purposes of the present description, the endoprosthesis implies a prosthesis fitted within a human organism, and the alloplastic materials imply materials compatible with the human tissues, such as the widely known polyethylene.

Those skilled in the art know of non-surgical methods of treatment of impotence (physical therapy, medicamentous therapy, etc.). These, however, often prove futile, particularly in cases of impotence being due to an organic lesion of the central nervous system, genital infantilism, injury of the penis, old age, or some diseases of the urogenital system.

There also exists a method of treatment of impotence by external prosthetic replacement'of the penis. Yet, this method, too, is inefficient in many cases. Besides, it has a number of serious disadvantages, the chief of them being due to the following facts: the prosthesis is too sophisticated and expensive; individual adjustment is a very complicated process; fitting of the prosthesis calls for a pause; the fact ofa man having a prosthesis is difficult to conceal from his woman partner; and finally, such a prosthesis involves the risk of irritation of the mucous membranes of the male and female genitals.

All the above considerations point to the need for further development of surgical methods of treatment which offer the following advantages: an endoprosthesis surgically fitted in the penis imparts to the latter a permanent elasticity (passive erection, the desired volume and length, requiring no fitting or removal of. the prosthesis); an endoprosthesis does not irritate the mucous membranes of the male and female genitals; endoprosthetic repair gives good results where the other methods of treatment fail; and endoprosthetic repair ensures a good cosmetic concealment of the fact of prosthesis.

There are various known methods of surgical therapy of impotence, whereby solid transplants made of a vari-,

ety of auto-, homoand alloplastic materials are fitted in the penis.

Thus, for example, it is known in the art to use an endoprosthesis formed by two bars of an alloplastic material polyethylene fitted in the cavernous body (see, for example, J. Med. Lib., 1965, 18, 365-369). The bars of this prosthesis are freely placed in the cavernous bodies, so that they are likely to be displaced or may even emerge out of the cavernous bodies. Besides, such displacements contribute to the formation of scar tissue and prevent the patient from getting back his. own erection.

Also known are endoprostheses for the penis formed by two bars placed in the cavernous bodies and-stitched to the surrounding tissues. These prostheses, though not obstructing the restoration of autoerection, are unreliable, for in many cases they are fastened in place insecurely.

And, finally, there is a known T-shaped prosthesis fitted between the cavernous bodies, with its cross-bar abutted against the pubic bone. Such a prosthesis does not provide for a volumetric increase of'the penis size. Besides, strength considerations require an increase in 2 the diameter of the cross-bar between the cavernous bodies, which may result in disrupting the functioning of the penis, for example by preventing the restoration of autoerection, and'causes pain to the patient. v

The known prostheses are completely immersed in the cavernous bodies or in thespace between the cavernous bodies (T-shaped prosthesis), which is fraught with injuries and adversely affects the chances of having autoerection restored.

It is an object of the present invention to improve the chances of. having autoerection restored.

It is another object 'of the presentinvention to provide for a permanent volumetric passive erection.

It is yet another object of the invention to provide for a more secure attachment of the endoprosthesis and for a reduction in traumatism during the operation.

It is herein contemplated that there shall be provided an endoprosthesis of such a shape that would be best adapted to the anatomy of the penis and that would provide for a maximum volumetric passive erection at a minimum cross-section of the bars. A I

These and other objects are attained by providing an endoprosthesis for the penis made of an alloplastic material and having a support limiting its travel in a longitudinal plane, which, in accordance with the invention, is defined by a pair of bars rigidly interconnected at one end by means of a cross-piece placed proximally at the pubic bone and serving as a support for the prosthesis, whereas the other ends of the bars have spherical bulges placed, when fitted in the cavernous body, close to the glans. V

The invention offers'an advantage which consists in that the cross-piece, ensuring the invariability of the spacing between the endoprosthesis bars, provides for a volumetric passive erection. In addition, the crosspiece. interacts with the pubic bone, thereby providing for a permanent lengthwise passive erection and for a secure attachment of the prosthesis.

The cross-piece is preferably bow-shaped, with the prominence turned toward the bulging ends of the bars, and disposed in a plane inclined at an angle of 50 to to the plane passing through the longitudinal axes of the bars. Such an embodiment of the crosspiece provides for the greatest possible degree of compatibility of the prosthesis with the penis anatomy and also for the optimum interaction of the'support with the pubic symphysis.

The surfaces of the bars facing each other may be formed concave, which reduces the traumatism of the cavernous bodies at a permanent volumetric passive erection and also assists in the restoration of autoerection.

In order that the endoprosthesis be fixed in the penis more conveniently, at the points of connection of the bars with the cross-piece there must be provided orifices through which ligatures can be passed. I

The method of. endoprosthetic repair with the pr posed prosthesis consists in that the albuginea tunica is incised at the base of the cavernous bodies and channels are formed .between the fascia and the albuginea tunica of the cavernous bodies of the penis; the bars of the endoprosthesis are inserted into the channels thus formed, with the spherical bulges of the bars directed toward the penis glans, until the bulging ends of the bars are immersed in the cavernous bodies near the glans and the cross-piece is immersed under the slingshaped and penis-retaining ligaments in the immediate vicinity of the pubic bone, and then the endoprosthesis is sutured to the surrounding tissues, passing the ligature through the orifices in the endoprosthesis.

Such a technique of endoprosthetic repair is less injurious for the cavernous bodies and provides for the simplicity and high reliability of attachment of the prosthesis, both at its proximal and distal ends.

The thickened ends of the endoprosthesis are preferably precovered with a homofascia, which permits increasing the size of the glans and contributes to the formation of a solid capsule between the bulge of the endoprosthesis and the glans, thereby improving the reliability of attachment of the distal end of the prosthesis, preventing bed sores and ruling out the possibility of perforation of the glans tissues.

The bar is best sutured with a homotendon, as such a method provides for a secure fixation of the proximal end of the endoprosthesis in the initial postoperative period, and subsequently promotes the implantation of the ligature in the tissues.

Embodiments of the present invention and the proposed method of endoprosthetic repair will now be described, by way of example, with reference to the accompanying drawings, wherein:

FIG. 1 is a plan view of an endoprosthesis, in accordance with the invention;

FIG. 2 is a view taken in the plane II-II of FIG. 1;

FIG. 3 is an endoprosthesis according to FIG. 1 with homofascia and a ligature;

FIG. 4 is a longitudinal view of a penis with an endoprosthesis fastened in place;

FIG. 5 is a view taken inplane V-V of FIG. 4;

FIG. .6 is a view taken in the plane VIVI of FIG. 4.

The endoprosthesis is formed by two bars 1 (FIG. 1) made of an alloplastic material, say polyethylene. Both bars are of an equal length which depends on the length of the penis; generally it ranges from 125 to 210 mm. At one end of the bars, which are positioned distally when installing the endoprosthesis in the penis, there are spherical bulges 2. The two other ends of the bars 1, which are positioned in the penis proximally, are rigidly coupled by a cross-piece 3. The surfaces of the bars 1 which face each other are concave (see FIG. 2). The cross-piece 3 is bow-shaped and lies in a plane which is inclined at an angle of from 50 to 70 to the plane passing through the longitudinal axes of the bars 1. Orifices 4 are provided at the points of connection of the bars 1 with the cross-piece 3 (FIG. 1).

Before installing the endoprosthesis in the penis, a homofascia 5 in the form of a cap is fitted over the spherical bulges 2 (FIG. 3), and a ligature 6, made of a homotendon for instance, is passed through the orifices 4. Instead of the homofascia, use can also be made of a homoalbuginea tunica.

The proposed method of endoprosthetic repair is as follows:

Having prepared the skin'of a penis 7 (FIG. 4) and the adjoining sections of the body, skin 8 and subcutaneous connective tissue 9 are incised, under anaesthesia, for a distance of some 5 cm at the base of the penis 7 on the dorsal surface thereof. Fascia 10 of the penis 7 is also incised along the line of the skin incision. Albuginea tunica ll of cavernous bodies 12 is pulled out through the skin incision at the base of the penis 7. Stay-sutures (not shown) are applied to the albuginea tunica ll of both the right and the left cavernous bodies 12 at glans 13 of the penis 7, and the albuginea tunica 11 is incised along the length of the cavernous bodies 12 for a distance of 0.9 cm. Then a capron purse-string suture is applied to the edges of each orifice in the cavernous bodies 12, the ends of the sutures being clamped. With the help of expander-probes (not shown) channels are provided for inserting the bulged ends 2 of the bars 1 of the endoprosthesis into the distal ends of the cavernous bodies 12 near the glans 13 of the penis 7; simultaneously the optimum length of the endoprosthesis is determined.

Closer to the base'of the penis 7, sections of the albuginea tunica ll of the cavernous bodies 12 are isolated both on the left and right. Stay-sutures are applied to these sections of the albuginea tunica 1 1. Then with the stay-sutures kept taut, a channel is formed with a curved clamp between the albuginea tunica 11 at the base of the penis 7, a ligament 14 retaining the penis 7 and a sling-like ligament 15. One of the bars of the endoprosthesis is passed through the channel thus formed. The endoprosthesis is placed with its rigid cross-piece 3 abutted against a pubic bone 16. Between the fascia 10 of the penis 7 and the albuginea tunica l 1, channels are formed about the upper lateral surface of the cavernous bodies 12 (see FIG. 5) with an expanderprobe, through which channels the bars 1 of the endoprosthesis are inserted.

A guide-probe (not shown) is successively inserted into each orifice of the cavernous bodies near the glans of the penis 7, and with the help of it the bulged ends 2 of the endoprosthesis bars are immersed into the lumen of the distal ends of the cavernous bodies 12 (also see FIG. 6). The edges of the orifices in the cavernous bodies 12 are united above the bars 1 of the endoprosthesis with the help of the earlier applied pursestring sutures.

With capron threads passed at the base of the endoprosthesis the base of the endoprosthesis is fastened to the albuginea tunica 11 of the right and left cavernous bodies 12 at the pubic bone 16.

According to the above technique of endoprosthesis implantation, the ligaments (retaining and sling-like) of the penis 7 are unimpaired, and the bars 1 are placed beside the cavernous bodies 12 leaving their lumen intact, with only the bulged ends 2 of the endoprosthesis inserted into the distalmost end of each cavernous body 12. Since the bars are in the main laid outside the lumen of the cavernous-bodies, the potential for an independent active erection of the penis is fully preserved.

Thus, the proposed prosthesis provides for the maximum passive erection of the penis both by length and by volume, irrespective of the degree and duration of the patients own autoerection, and also improves the fastening of the prosthesis inside the penis.

The clinical application of endoprosthesis in a surgical treatment of mens impotence of varying etiologyis illustrated y as eport at twp qts est liq it in a clinic of traumatology and orthopedics.

A 20-year old patient was admitted to the clinic with complaints of impotence. Libido was preserved. The patient had undergone medicamentous treatment for about one year previously without success. An objective examination of the patient revealed no organic lesions of the nervous system, nor genital infantilism, nor any other pathology. Surgical intervention endoprosthetic repair of the penis was performed on the patient for impotence which was manifest as disturbances of the erection function. The operation was performed under general anaesthesia. The skin and subcutaneous connective tissue were incised for about 5 cm at the base of the penis about its dorsal surface. The connective tissue and the fascia of the penis were incised along the line of the skin incision. Through the skin incision at the base of the penis the albuginea tunica of the cavernous bodies was pulled out, with the sections of the albuginea tunica adjoining the penis glans mobilized into the wound. Stay-sutures were applied to the albuginea tunica of the right and left cavernous bodies at the glans, and the albuginea tunica was incised along the length of the cavernous bodies for a distance of 0.9 cm. A capron purse-string suture was applied to the edges of each orifice in the cavernous bodies, the ends of the sutures clamped. With the help of expander-probes, a space was created for the ends of the endoprosthesis in the distal ends of the cavernous bodies near the glans, with the optimum length of the endoprosthesis simultaneously set by the graduations of the probe (in this case it was set at 170 mm). Through the orifices at the cross-piece of the endoprosthesis thus chosen capron threads were passed. Closer to the base of the penis, sections of the albuginea tunica of the cavernous bodies were isolated both on the right and on the left, and stay-sutures were applied to these sections. With the stay-sutures kept taut, a channel was formed with a curved clamp between the albuginea tunica at the base of the penis, the penis-retaining ligament and the sling-like ligament. Through the tunnel thus formed one bar of the endoprosthesis was passed. The endoprosthesis was installed with its cross-piece abutted against the pubic bone. Fascia] homocaps were fitted over the rounded and thickened ends of the bars. With special tapering expander-probes, channels were formed between the fascia of the penis and the albuginea tunica on the upper lateral surface of the cavernous bodies, and the bars of the endoprosthesis were immersed in these channels. A guide-probe, successively inserted into each orifice of the cavernous bodies at the glans, was used to immerse the homofascia-covered ends of the endoprosthesis into the lumen of the distal ends of the cavernous bodies. The edges of the orifices in the cavernous bodies were joined above the endoprosthesis bars with the help of the previously applied purse-string sutures. With capron threads passed at the base of the endoprosthesis, the latter was fixed to the albuginea tunica of the right and left cavernous bodies at the pubic bone. Sutures were applied to the wound in layers. The penis was ligature-fastened in an elevated position to the front abdominal wall.

There were no complications in the postoperative period. The sutures were removed on the 12th day after surgery, and on the 14th day the patient wasdischarged. The oedema of the penis and local pain sensations disappeared within three weeks of the operation. The first attempts at coitus, made three months after the operation, were accompanied by transient pain sensations in the penis; these disappeared altogether soon afterward. At present the patient, who has been subjected to endoprosthetic repair of the penis according to this invention, reports that he has got autoerection back, performs coitus normally and is satisfied with the results of the operation.

A -year old patient had for nearly 30 years suffered from impotence which had resulted from a traumatic injury of the penis. The patient had been continuously treated throughout the entire three decades: took a variety of drugs, underwent physical therapy and was even subjected to surgical intervention transplantation of bovine testicular tissues according to Rumyantsev. Nevertheless, all the treatment strategies used had failed. The patient was subjected to surgical endoprosthetic repair of the penis according to the present invention for impotence due to inadequate autoerection. The technique of the operation was similar to the one discussed above. The bars of the endoprosthesis were mm long. The postoperative period passed without complications. On the 20th day after the operation the patient was discharged from the clinic. 4 months after the operation the patient got married and performed'a successful coitus. Subsequently led a regular sexual life. The patient reports an improved general state of health, a higher tonicity, better sleep, etc.

Thus, the advantages of the above-discussed technique of endoprosthetic repair of the penis stem from a special shape of endoprosthesis, whereby it can be securely fastened to the penis tissues with the help of a homotendon, homofascia, homoalbuginea tunica, or other plastic material. Furthermore, thanks to its configuration, the endoprosthesis of this invention does not obstruct the restoration of autoerection. The use of an endoprosthesis of the described construction and the combination of an alloplastic endoprosthesis with a biological fastening material provided for the following:

.a state of permanent passive erection, as well as the desired length and shape of the penis irrespective of the degree and duration of autoerection;

a possibility for having autoerection restored;

reliability and stability of endoprosthesis fastening, which rules out excessive traumatization of the tissues by the endoprosthesis;

a normal mobility of the penis;

a pain-free coitus; and

a good cosmetic effect permitting of concealing the fact of endoprosthetic repair. v

The secure fixation of the-endoprosthesis in the tissues did not interfere with the functional position of the penis either in case of passive erection or autoerection.

So far about 210 operationshave been performed with various follow-up periods. Follow-up results show that the proposed endoprosthesis simplifies the treatment of impotence, and that it is effective and reliable.

The patients, who have undergone this kind of endoprosthetic repair, report that the results are stable and, in most cases, that they have autoerection back. The operation has another manifest benefical effect: improved tonicity of the organism,'higher spirits, better sleep, .and so forth. The patients would resume sexual life three months after surgery.

What I claim is:

1. An endoprosthesis for the-penis comprising a pair of elongated bars constructed from an alloplastic material, a transverse cross-piece rigidly interconnecting respective ends of said bars, said cross-piece being disposed proximally at the pubic bone and defining means for supporting the prosthesis, the other respective ends of said bars each having a spherical bulge positioned at the glans when said bars are placed in the cavernous bodies.

2. An endoprosthesis as in claim 1, wherein said cross-piece is bow-shaped, with the prominence of the bow facing the bulged ends of the bars, said crosspiece being disposed in a plane inclined at an angle of 50 to 70 to the plane passing through the longitudinal axes of the bars.

3. An endoprosthesis as in claim 2, wherein the surfaces of the bars facing each other are concave.

4. An endoprosthesis as in claim 1, wherein at the points of connection of said bars with said cross-piece, orifices are provided, wherethrough ligatures can be passed.

5. A method of endoprosthetic repair utilizing a prosthesis comprising a pair of elongated bars rigidly interconnected at respective ends by a cross-piece with the other respective ends of the bars each having a spherical bulge, said method comprising the steps of successively incising the skin, the subcutaneous connective tissue and the fascia of the penis at the base of the cavernous bodies, forming channels between the fascia and the albuginea tunica of the cavernous bodies, inserting the bars of the endoprosthesis in the channels thus formed between the fascia and the albuginea tunica, with the spherical bulges on the ends of the bars directed through said channel toward the glans until the bulged ends of the bars are immersed in the cavernous bodies near the glans, and until the cross-piece of the endoprosthesis is immersed under the sling-like and penis-retaining ligaments in the immediate vicinity of the pubic bone, and thereafter suturing the endoprosthesis to the surrounding tissues, with the ligature being passed through orifices in said endoprosthesis.

6. A method as in claim 5, whereby the bulged ends of the endoprosthesis are previously covered with a homofascia.

7. A method as in claim 5, whereby the endoprosthesis is sutured with homotendons. 

1. An endoprosthesis for the penis comprising a pair of elongated bars constructed from an alloplastic material, a transverse cross-piece rigidly interconnecting respective ends of said bars, said cross-piece being disposed proximally at the pubic bone and defining means for supporting the prosthesis, the other respective ends of said bars each having a spherical bulge positioned at the glans when said bars are placed in the cavernous bodies.
 2. An endoprosthesis as in claim 1, wherein said cross-piece is bow-shaped, with the prominence of the bow facing the bulged ends of the bars, said crosspiece being disposed in a plane inclined at an angle of 50* to 70* to the plane passing through the longitudinal axes of the bars.
 3. An endoprosthesis as in claim 2, wherein the surfaces of the bars facing each other are concave.
 4. An endoprosthesis as in claim 1, wherein at the points of connection of said bars with said cross-piece, orifices are provided, wherethrough ligatures can be passed.
 5. A method of endoprosthetic repair utilizing a prosthesis comprising a pair of elongated bars rigidly interconnected at respective ends by a cross-piece with the other respective ends of the bars each having a spherical bulge, said method comprising the steps of successively incising the skin, the subcutaneous connective tissue and the fascia of the penis at the base of the cavernous bodies, forming channels between the fascia and the albuginea tunica of the cavernous bodies, inserting the bars of the endoprosthesis in the channels thus formed between the fascia and the albuginea tunica, with the spherical bulges on the ends of the bars directed through said channel toward the glans until the bulged ends of the bars are immersed in the cavernous bodies near the glans, and until the cross-piece of the endoprosthesis is immersed under the sling-like and penis-retaining ligaments in the immediate vicinity of the pubic bone, and thereafter suturing the endoprosthesis to the surrounding tissues, with the ligature being passed through orifices in said endoprosthesis.
 6. A method as in claim 5, whereby the bulged ends of the endoprosthesis are previously covered with a homofascia.
 7. A method as in claim 5, whereby the endoprosthesis is sutured with homotendons. 